Clincal Trials and Performance studies
New EU regulations leads to changed processes when you perform a clinical trial/performance study that includes biobank samples. On this page we explain it all.
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Research
Find out how to access samples in Swedish biobanks for research, method development or clinical trials. This includes information regarding the different application processes and some of the services which you can use as a researcher.
Access to samples
The Swedish Biobank Act (2023:38) allows human biological material that have been collected and/or stored for healthcare purposes to be used in research and clinical trials if the patient/donor has given consent.
To start a sample collection or gain access to existing biobank samples, an agreement with a biobank and an approval by the Swedish Ethical Review Authority is required. Clinical trials for medical products must also be approved by the Swedish Medical Products Agency.
Documents, Application Forms and Instructions on how to access biobanks samples and complete an application can be found at our documents page.
For information regarding how to access samples for clinical trials, please see our clinical trials information page.
New Biobank Act
The Swedish Biobanks in Medical Care Act was replaced by a new Swedish Biobank Act, effective July 1, 2023.
Learn more about the legislation
Application procedures
A biobank application is always required for using biobank samples for research purposes. The application procedure may differ depending on your study design and sample collection.
Support services
There are several services which you can use as a researcher to get the support you need regarding access to biobank samples in Swedish biobanks. Click the toggle menus below to find out more.
Biobank Coordinators
If you are a researcher planning a study involving human biological samples and need advice on how to access existing biobank samples or want to start a sample collection, you can contact the Biobank Coordinator (Biobankssamordnaren in the Swedish healthcare region where you are based.
Contact information to the Biobank Coordinators (Biobankssamordnare)
Sample service coordinator
Sample service coordinators provide support to researchers in terms of collecting and accessing samples, as well as providing guidance to biobank services and existing cohorts/sample collections open to collaboration. The purpose is to stimulate research using Sweden’s rich biobanking sample collections.
For contact information to the Sample service coordinators (Provservice koordinatorer), please see our “Tjänstekarta”, a digital map including contact details.
Regional biobank centres
Regional Biobank Centres (RBC) is a service- and centre of excellence that handles multicentre applications and provides guidance and support to researchers, pharmaceutical companies and the public regarding the Swedish Biobanks in Medical Care Act.
The RBC is also responsible for administering, updating and establishing Biobank Sweden’s joint documents.
Useful resources
- Guide to biobanks in Sweden (Currently updating) – This document describes biobanks in Sweden and provides guidance on what researchers and companies should do to get access to existing samples in Swedish biobanks, as well as requirements for collecting new samples from persons in Sweden.
- Biobank Sweden’s glossary – is one of the principal documents to obtain a uniform, nationwide interpretation of the Biobanks in Medical Care act and to create common procedures. The glossary is maintained and updated by Biobank Sweden and contains terminology concerning biobank samples and guidelines on how to utilise the samples in healthcare and research.
- National registers and Quality registers – See our summary of the Swedish national registers and quality registers
- BBMRI-ERIC Directory – is a tool that collects and makes information about biobanks and research sample collections, open for collaborations, available. Biobank Sweden is the Swedish node for BBMRI-ERIC Directory.
Latest update: 2024-11-05
